Double valve Implantation. Long-term evaluation of 8 different bioprostheses.

From January 1976 through December 1987, 194 patients with a mean age of 43.3 +/- 13.7 years (range, 11 to 74 years) underwent double (mitral and aortic) replacement of native valves with 8 types of bioprostheses: Carpentier-Edwards, 127 valves; Hancock, 76 valves; Liotta-Bioimplant, 57 valves; Ionescu-Shiley, 53 valves; Vascor, 27 valves; Carpentier-Edwards Pericardial, 22 valves; Angell-Shiley, 20 valves; and Implamedic, 6 valves. Concomitant cardiac procedures were performed in 25 patients (12.8%). There were 18 operative deaths (9.27%). Our retrospective analysis was restricted to 352 bioprostheses implanted in the 176 patients who survived surgery and were considered at risk for valve tissue failure. The overall cumulative duration of follow-up was 1,174.1 patient-years (range, 1 to 13 years). The durations of follow-up for specific valves were: Carpentier-Edwards, 920.2 valve-years; Hancock, 383.8 valve-years; Liotta-Bioimplant, 310.2 valve-years; Ionescu-Shiley, 357.7 valve-years; Vascor, 131.2 valve-years; Carpentier-Edwards Pericardial, 52.0 valve-years; Angell-Shiley, 167.0 valve-years; and Implamedic, 31.0 valve-years. Thirty patients had thromboembolic accidents, for a linearized incidence of 2.5% per patient-year. At 13 years, the actuarial freedom from thromboembolic accidents was 85.8% +/- 10.7%. Nine patients had endocarditis, for a linearized incidence of 0.7% per patient-year. At 13 years, the actuarial freedom from endocarditis was 92.0% +/- 1.5%. Twenty-four patients had valve tissue failure, for a cumulative linearized incidence of 1.87% per valve-year. The cumulative actuarial probability of freedom from valve tissue failure was 78.6% +/- 3.7% at 10 years and 51.2% +/- 10.7% at 13 years. The 24 patients with valve tissue failure all underwent reoperation: 20 of these had double valve replacement, 3 had aortic valve replacement alone, and 1 had mitral valve replacement alone. The mean interval between initial valve implantation and reoperation was 66.9 +/- 28.8 months. At reoperation, the hospital mortality was 15.1% (5 patients). This study showed that the long-term results of valve implantation are not significantly influenced by either prosthesis design or material. Moreover, the incidence of degenerative change was similar in the aortic and mitral positions.